News Highlights – July 2021


The month of July started with College of American Pathologists releasing an update to the CAP Cancer Protocols with updated report guidance for routinely tested biomarkers. Among the protocols with significant review are lung and head and neck biomarkers, as well as quantitative IHC reporting.

On the CDx field, Foundation Medicine got two new CDx approvals: ALK for NSCLC patients in association with Takeda’s brigatinib and MET exon 14 skipping for Novartis’ capmatinib. In Europe, Agilent’s PD-L1 IHC 22C3 pharmDx assay expanded its CE mark for identifying NSCLC patients with tumor PD-L1 expression ≥ 50% (TPS) eligible for Sanofi’s cemiplimab. To enable patient access to biomarker testing, OncoDNA, Tamkin Al-Seha Medical and Bayer also reached a partnership to provide NTRK testing for patients in Saudi Arabia. Another important program to provide free access to biomarker testing of liver cancer patients has come to life due to an agreement between Genetron and the Defang County of Guizhou in China.

Liquid biopsy also saw important new data with Agilent publishing on the validation of cfDNA analysis for detection of ALK fusions as well as monitoring emerging resistance to targeted therapies. Likewise, Tempus showed high sensitivity and specificity of its xF liquid biopsy test in a comparative study with other available tests.

Digital pathology reached a major milestone in Europe, with Ibex signing a deal with Unilabs to deploy Ibex's AI platform across 16 European countries for diagnosing cancer, and partnering with Sana Kliniken Berlin-Brandenburg to provide AI-aided pathology platforms to German hospitals.

Finally, concerning most recent drug approvals, Merk’s pembrolizumab reached 30 different different indications in the US with this month’s approvals, which included early-stage TNBC with chemo in neoadjuvant setting, locally advanced cutaneous squamous cell carcinoma in adjuvant treatment and as a third-line therapy for gastric Cancer. FDA also approved Astellas’ enfortumab vedotin-ejfv for urothelial cancer, who failed one or more lines of therapies and are ineligible for cisplatin-containing chemotherapy. In Europe, BMS' nivolumab obtained approval as adjuvant treatment for esophageal or gastroesophageal junction cancer patients with residual pathologic disease after chemoradiotherapy.
Summary of news (with links)

Regulatory decisions on Rx (7)


Dx approvals, market access and reimbursement (8)


Latest diagnostic developments, investment and CDx deals (9)


Guidelines (1)


Clinical trials and drug development (12)


Observational studies (1)


Merge and acquisitions (2)


Partnerships (28)


Giovanni Dothel, PhD - - Inflection Point Biomedical Advisors

Jaume Calafell - - Inflection Point Biomedical Advisors